LifeShield Infusion Safety Software Suite

GUDID 00887709127227

GTIN for 17003-02, 1/EA

ICU MEDICAL FLEET SERVICES, LLC

Infusion pump medication-dosage application software

• Primary Device ID: 00887709127227
• NIH Device Record Key: 22543cfa-474c-46a0-a1a5-e537eb091278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeShield Infusion Safety Software Suite
• Version Model Number: 17003-02
• Company DUNS: 830767898
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709127227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242117

FDA Product Code

• PHC: Infusion safety management software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

On-Brand Devices [LifeShield Infusion Safety Software Suite]

• 00887709127241: GTIN for 17002-02, 1/EA
• 00887709127234: GTIN for 17005-02, 1/EA
• 00887709127227: GTIN for 17003-02, 1/EA